An Open-Label Study of a Novel JAK-inhibitor, INCB052793,... | NCT02265510 | Trialant
NCT02265510
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Apr 17, 2020Actual
Enrollment
83Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors
Advanced Malignancies
Metastatic Cancer
Interventions
INCB052793
gemcitabine
nab-paclitaxel
dexamethasone
Carfilzomib
bortezomib
lenalidomide
azacitidine
INCB052793
pomalidomide
INCB050465
INCB039110
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02265510
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 52793-101
Secondary IDs
Not provided
Brief Title
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
Official Title
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Apr 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03906344No longer available
Start Date
Sep 10, 2014Actual
Primary Completion Date
Feb 27, 2019Actual
Completion Date
Feb 27, 2019Actual
First Submitted Date
Sep 29, 2014
First Submission Date that Met QC Criteria
Oct 10, 2014
First Posted Date
Oct 16, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 27, 2020
Results First Submitted that Met QC Criteria
Apr 6, 2020
Results First Posted Date
Apr 17, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 6, 2020
Last Update Posted Date
Apr 17, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Advanced Malignancies
Metastatic Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
83Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1a: INCB052793 Monotherapy
Experimental
Drug: INCB052793
Phase 1b: INCB052793 Combination Therapy
Experimental
Drug: gemcitabine
Drug: nab-paclitaxel
Drug: dexamethasone
Drug: Carfilzomib
Drug: bortezomib
Drug: lenalidomide
Drug: azacitidine
Drug: INCB052793
Drug: pomalidomide
Drug: INCB050465
Phase 2: INCB052793 and itacitinib Combination Therapy
Experimental
Drug: azacitidine
Drug: INCB052793
Drug: INCB039110
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB052793
Drug
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
Phase 1a: INCB052793 Monotherapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
Phase 2: Objective Response Rate (ORR) in Hematological Malignancies
ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.
Baseline through end of study (Up to approximately 4.5 years)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Phase 1a
Aged 18 years or older
Histologically or cytologically confirmed solid tumor or hematologic malignancy
Life expectancy of 12 weeks or longer
Must have received ≥ 1 prior treatment regimen
Must not be a candidate for potentially curative or standard of care approved therapy
Phase 1b
Aged 18 years or older
Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion
Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and measureable/evaluable disease
Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome
Cohort H: Individuals diagnosed with lymphoma
Prior therapy:
Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2 prior treatment regimens
Cohort F: May have received any number of prior treatment regimens or be treatment-naïve
Cohort H: Must have relapsed from or have been refractory to available treatments
Phase 2
Aged 18 years or older
Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic syndrome
Prior therapy:
Cohorts I and J: Must have failed prior therapy with a hypomethylating agent (HMA)
Exclusion Criteria:
Prior receipt of a JAK1 inhibitor (Phase 1a only)
Known active central nervous system metastases and/or carcinomatous meningitis
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor (Phase 1b and Phase 2 only, as appropriate to treatment cohort)
Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ekaterine Asatiani, M.D.
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Birmingham
Alabama
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants with advanced malignancies,acute myeloid leukemia(AML),high-risk myelodysplastic syndrome(MDS)who failed prior therapy with hypomethylating agents(HMA)enrolled to dose escalation(Part 1),expansion(Part 2) of INCB052793 monotherapy and combination therapy cohorts.CohortsA,C,D,E,G,H had no enrollment at the time of premature termination.
Recruitment Details
Participants took part in the study at 11 investigative sites in United States from 10 September 2014 to 27 February 2019. This study was prematurely terminated due to lack of efficacy.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
FG001
Phase 1a TGA - INCB052793 25 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 2, 2017
Feb 25, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
gemcitabine
Drug
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Gemzar®
nab-paclitaxel
Drug
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Abraxane®
dexamethasone
Drug
Dexamethasone administered orally at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Carfilzomib
Drug
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Kyprolis®
bortezomib
Drug
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Velcade®
lenalidomide
Drug
Lenalidomide administered orally at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Revlimid®
azacitidine
Drug
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Phase 2: INCB052793 and itacitinib Combination Therapy
Vidaza®
INCB052793
Drug
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
Phase 1b: INCB052793 Combination Therapy
Phase 2: INCB052793 and itacitinib Combination Therapy
pomalidomide
Drug
Pomalidomide administered orally at the protocol-specified dose and frequency.
Phase 1b: INCB052793 Combination Therapy
Pomalyst®
INCB050465
Drug
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
Phase 1b: INCB052793 Combination Therapy
INCB039110
Drug
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
Phase 2: INCB052793 and itacitinib Combination Therapy
itacitinib
Baseline through end of study (Up to approximately 4.5 years)
Phase 2: Number of Participants With at Least One TEAE and SAE
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at Day 1.
Cycle 1, Day 1
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 1, Day 1
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time t
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 1, Day 1
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
Cycle 1, Day 15
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Minimum observed plasma concentration measured at steady state (Day 15).
Cycle 1, Day 15
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 1, Day 15
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Cycle 1, Day 15
Phase 1a, Part 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 1, Day 15
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.
Cycle 2, Day 1
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1
Cycle 2, Day 1
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 2, Day 1
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 2, Day 1
Phase 1a, Part 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 2, Day 1
West Hollywood
California
United States
New Haven
Connecticut
United States
Atlanta
Georgia
United States
Chicago
Illinois
United States
Indianapolis
Indiana
United States
Hackensack
New Jersey
United States
New York
New York
United States
Durham
North Carolina
United States
Portland
Oregon
United States
Greenville
South Carolina
United States
Site 2
Nashville
Tennessee
United States
Nashville
Tennessee
United States
Dallas
Texas
United States
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria
FG002
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria.
FG003
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
FG004
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
FG005
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
FG006
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21day cycles until they met treatment discontinuation criteria.
FG007
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
FG008
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0034 subjects
FG0043 subjects
FG0056 subjects
FG0063 subjects
FG0074 subjects
FG0084 subjects
FG0097 subjects
FG0105 subjects
FG01116 subjects
FG0129 subjects
FG01310 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0034 subjects
FG0043 subjects
FG0056 subjects
FG0063 subjects
FG0074 subjects
FG0084 subjects
FG0097 subjects
FG0105 subjects
FG01116 subjects
FG0129 subjects
FG01310 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
Disease Progression
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety evaluable population included all subjects enrolled in the study who receivedat least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
BG001
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
BG002
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
BG003
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
BG004
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
BG005
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
BG006
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
BG007
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
BG008
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0026
BG0034
BG0043
BG0056
BG0063
BG0074
BG0084
BG0097
BG0105
BG01116
BG0129
BG01310
BG01483
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.7± 8.08
BG00159.0± 9.85
BG00257.0± 13.19
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG0003
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
ID
Title
Description
OG000
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
OG001
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
OG002
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
OG003
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
OG004
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
OG005
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
OG006
Phase 1a TGB - INCB052793 25 mg
Units
Counts
Participants
OG0003
OG0013
OG0026
OG003
Title
Denominators
Categories
TEAE
Title
Measurements
OG0003
OG0013
OG0026
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
OG010
OG011
Other
Descriptive Statistics
The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
Primary
Phase 2: Objective Response Rate (ORR) in Hematological Malignancies
ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.
Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline through end of study (Up to approximately 4.5 years)
ID
Title
Description
OG000
Phase 2 Cohort I-INCB052793 +Azacytidine (AML)
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with HMA-refractory AML in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
OG001
Phase 2 Cohort I-INCB052793 +Azacytidine (MDS)
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
OG002
Phase 2 Cohort J-Itacitinib +Azacitidine (AML)
Secondary
Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.
Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline through end of study (Up to approximately 4.5 years)
ID
Title
Description
OG000
Phase 1a TGA - INCB052793 in Solid Tumors
INCB052793 tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
OG001
Phase 1a TGB - INCB052793 in Lymphoma
INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
Secondary
Phase 2: Number of Participants With at Least One TEAE and SAE
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Posted
Mean
Standard Deviation
nM
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
ID
Title
Description
OG000
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
OG001
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
OG002
Secondary
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Posted
Median
Full Range
hours (hr)
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
ID
Title
Description
OG000
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
OG001
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
Secondary
Phase 1a, 1b, and Phase 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Posted
Mean
Standard Deviation
nM*hr
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
ID
Title
Description
OG000
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
OG001
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
Secondary
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Posted
Mean
Standard Deviation
nM
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Units
Counts
Participants
OG000
Secondary
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib
Tmax is the time to maximum (peak) observed plasma drug concentration.
The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Posted
Median
Full Range
hr
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Units
Counts
Participants
OG000
Secondary
Phase 1a, 1b, and Phase 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Posted
Mean
Standard Deviation
nM*hr
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Units
Counts
Participants
OG000
Secondary
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at Day 1.
Data was not collected as no participants were enrolled in Part 2 of the study.
Posted
Cycle 1, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration.
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 1, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time t
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 1, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG000
Secondary
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 1, Day 15
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Minimum observed plasma concentration measured at steady state (Day 15).
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 1, Day 15
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration.
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 1, Day 15
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 1, Day 15
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG000
Secondary
Phase 1a, Part 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 1, Day 15
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.
Data was not collected as no participants were enrolled in Part 2 of the study.
Posted
Cycle 2, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1
Data was not collected as no participants were enrolled in Part 2 of the study.
Posted
Cycle 2, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Tmax is the time to maximum (peak) observed plasma drug concentration.
Data was not collected as no participants were enrolled in Part 2 of the study.
Posted
Cycle 2, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Secondary
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Data was not collected as no participants were enrolled in Part 2 of the study.
Posted
Cycle 2, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG000
Secondary
Phase 1a, Part 2: AUC0-Ï„: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
AUC0-Ï„ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Data was not collected as no participants were enrolled in Part 2 of the study
Posted
Cycle 2, Day 1
ID
Title
Description
OG000
Phase 1a Part 2 Expasion Cohort- INCB052793
INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
Units
Counts
Participants
OG0000
Time Frame
From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
2
3
0
3
3
3
EG001
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
0
3
1
3
3
3
EG002
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
2
6
0
6
6
6
EG003
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
2
4
2
4
4
4
EG004
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
1
3
3
3
3
3
EG005
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
3
6
2
6
6
6
EG006
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 248.7 days).
2
3
1
3
3
3
EG007
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 342.8 days).
1
4
2
4
4
4
EG008
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 76.3 days).
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 28-day cycle (Up to mean duration of exposure of approximately 53.6 days).
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 151.2 days).
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 142.1 days).
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 86.2 days).
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 143 days).
6
10
8
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastrointestinal haemorrhage
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected7 at risk
EG0100 affected5 at risk
EG0110 affected16 at risk
EG0120 affected9 at risk
EG0130 affected10 at risk
Intestinal obstruction
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Embolism
Vascular disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Herpes zoster
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Encephalopathy
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Spinal cord compression
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lung infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oral fungal infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia fungal
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Septic arthritis staphylococcal
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Staphylococcal sepsis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Transfusion-related circulatory overload
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tachycardia
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
myocardial ischaemia
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cardiac failure
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Renal failure acute
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chloroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
ECG signs of myocardial ischaemia
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG0030 affected4 at risk
EG0043 affected3 at risk
EG0051 affected6 at risk
EG0061 affected3 at risk
EG0071 affected4 at risk
EG0081 affected4 at risk
EG0093 affected7 at risk
EG0102 affected5 at risk
EG01110 affected16 at risk
EG0122 affected9 at risk
EG0130 affected10 at risk
Febrile neutropenia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Angina pectoris
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Palpitations
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tachycardia
Cardiac disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blepharospasm
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Conjunctival haemorrhage
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Eye oedema
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Eye pain
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Eye swelling
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Periorbital oedema
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Scleral haemorrhage
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vision blurred
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Visual impairment
Eye disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0022 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Anal pruritus
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anal ulcer
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
17.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Dental caries
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gingival hyperplasia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Malabsorption
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0023 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oesophagitis
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tongue disorder
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0021 affected6 at risk
EG003
Application site pruritus
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Catheter site bruise
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Catheter site erythema
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected6 at risk
EG003
Device occlusion
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Energy increased
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Facial pain
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0023 affected6 at risk
EG003
Influenza like illness
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection site bruising
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection site erythema
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection site pain
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection site reaction
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Localised oedema
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Malaise
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mass
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Medical device pain
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nodule
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Oedema
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Peripheral swelling
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0022 affected6 at risk
EG003
Temperature intolerance
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vessel puncture site bruise
General disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Jaundice
Hepatobiliary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Graft versus host disease in skin
Immune system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bacteriuria
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Candida infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chronic sinusitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Clostridium difficile colitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Corona virus infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Device related infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Empyema
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Eye infection bacterial
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Folliculitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fungal skin infection
Infections and infestations
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Gingival abscess
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gingivitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Herpes simplex
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Herpes zoster
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hordeolum
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lung infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia fungal
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash pustular
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rhinitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Staphylococcal infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Staphylococcal skin infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tooth infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Laceration
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Periorbital contusion
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0024 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood bilirubin increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood cholesterol increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood fibrinogen decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood iron increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood magnesium decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood phosphorus increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood triglycerides increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood urea increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
C-reactive protein increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram ST segment abnormal
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram abnormal
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Haemoglobin decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Human papilloma virus test positive
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neutrophil count decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Platelet count decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected6 at risk
EG003
Platelet count increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Reticulocyte count decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Reticulocyte count increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Serum ferritin increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Staphylococcus test positive
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Troponin I increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
White blood cell count decreased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
White blood cell count increased
Investigations
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0022 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Iron overload
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Amnesia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Aphasia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Cerebrovascular accident
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Dizziness
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypogeusia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Memory impairment
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Paraplegia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Presyncope
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus headache
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Somnolence
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Speech disorder
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tension headache
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Anxiety
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Confusional state
Psychiatric disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Depression
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hallucination
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Irritability
Psychiatric disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mental status changes
Psychiatric disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Renal failure acute
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract pain
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Testicular oedema
Reproductive system and breast disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Testicular pain
Reproductive system and breast disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tooth extraction
Surgical and medical procedures
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Haematoma
Vascular disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hot flush
Vascular disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Adrenal insufficiency
Endocrine disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tremor
Nervous system disorders
17.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
OG007
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
OG008
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
4
OG0043
OG0056
OG0063
OG0074
OG0084
OG0097
OG0105
OG01116
4
OG0043
OG0056
OG0063
OG0074
OG0084
OG0097
OG0105
OG01116
SAE
Title
Measurements
OG0000
OG0011
OG0020
OG0032
OG0043
OG0052
OG0061
OG0072
OG0082
OG0095
OG0104
OG01114
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
OG003
Phase 2 Cohort J-Itacitinib +Azacitidine (MDS)
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle .
Units
Counts
Participants
OG0006
OG0013
OG0028
OG0032
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0030
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Other
Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.
OG002
Phase 1a TGB - INCB052793 in MDS/MPN
INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
OG003
Phase 1a TGB - INCB052793 in MM
INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
OG004
Phase 1b Cohort B - INCB052793 + Dexamethasone in MM
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
OG005
Phase 1b Cohort F-INCB052793 +Azacytidine in AML
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
OG006
Phase 1b Cohort F-INCB052793 +Azacytidine in MDS
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
OG007
Phase 1b Cohort F-INCB052793 +Azacytidine in MDS/MPN
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Units
Counts
Participants
OG00025
OG0014
OG0024
OG0033
OG0047
OG00512
OG0067
OG0072
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
OG0054
OG0063
OG0072
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Other
Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Units
Counts
Participants
OG0009
OG00110
Title
Denominators
Categories
TEAE
Title
Measurements
OG0009
OG00110
SAE
Title
Measurements
OG0007
OG0018
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
OG003
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
OG004
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
OG005
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Units
Counts
Participants
OG0003
OG0016
OG0027
OG0037
OG0043
OG0053
OG0066
OG0076
OG00815
OG0098
Title
Denominators
Categories
Title
Measurements
OG000522± 126
OG0011110± 324
OG0021120± 543
OG0032050± 1070
OG0041840± 563
OG0052890± 1690
OG006928± 263
OG0071270± 856
OG0081480± 588
OG0091610± 745
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
OG002
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
OG003
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
OG004
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
OG005
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
Units
Counts
Participants
OG0003
OG0016
OG0027
OG0037
OG0043
OG0053
OG0066
OG0076
OG00815
OG0098
Title
Denominators
Categories
Title
Measurements
OG0001.1(0.48 to 2.0)
OG0010.76(0.47 to 2.0)
OG0022.0(0.50 to 4.0)
OG0031.1(1.0 to 2.1)
OG0042.2(1.1 to 4.0)
OG0052.0(0.43 to 2.1)
OG0061.0(0.43 to 2.0)
OG0071.1(0.58 to 7.7)
OG0081.1(0.47 to 2.1)
OG0090.51(0.33 to 2.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
OG002
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
OG003
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
OG004
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
OG005
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle .
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle .
Units
Counts
Participants
OG0003
OG0016
OG0027
OG0037
OG0043
OG0053
OG0066
OG0076
OG00815
OG0098
Title
Denominators
Categories
Title
Measurements
OG0004750± 1380
OG0019170± 4290
OG0028430± 2520
OG00314700± 6670
OG00418300± 10600
OG00527800± 12300
OG0066390± 1690
OG0079580± 6710
OG00810200± 5260
OG0099380± 4390
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
9
Title
Denominators
Categories
Title
Measurements
OG0001310± 638
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
9
Title
Denominators
Categories
Title
Measurements
OG0003.5(1.0 to 8.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
9
Title
Denominators
Categories
Title
Measurements
OG0009870± 7350
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Other
The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.